ABSTRACT

Background: Compression therapy is considered the mainstay of venous leg ulcer (VLU) treatment [1] and, along with standard care, has the potential to heal 50%-75% of VLUs [1][2]. Despite existing references and guidelines, many patients with VLUs who are treated in primary care settings do not receive adequate compression therapy due to several factors, some related to patients (e.g., adherence) and some to clinicians (e.g, application skills, etc) [3].

Two-layer gradient compression stockings that deliver 40 mmHg pressure at the ankle can be considered an effective alternative to multi-component compression systems (e.g., 4LB) (Grade 2B).

2C

Intermittent pneumatic compression (IPC) therapy can be used associated with compression bandages when all other compression therapy methods have failed or on patients that do not tolerate multi-component compression systems or high compression gradient stockings (Grade 2C).

2C

To decrease risk of ulcer recurrence in patients with a healed VLU we suggest compression therapy with gradient compression stockings at the highest pressure patients can tolerate (Grade 2C).

When considering compression devices, multicomponent systems with an elastic layer (e.g. 4LB), short stretch bandages and other types of compression bandages/wraps can be effective choices depending on factors such as patient comorbidities, tolerance to compression, characteristics of the ulcer, availability of resources, clinicians’ experience and familiarity with the compression method, and support from caregivers. For decision support on choices for effective compression therapy, see "How to Select Adequate Compression Therapy Pressure Levels and Products". For information on major brands of compression devices, see "Compression Brands Quick Reference".

Background

Compression therapy is considered the mainstay of VLU treatment [1] and, along with standard care, has the potential to heal 50%-75% of VLUs [1][2].

Despite existing references and guidelines, many patients with VLU who are treated in primary care settings do not receive compression therapy. In Europe records indicate that only 10-53% of patients with VLU receive adequate compression therapy [3]. In contrast, there is evidence that at European specialist centers, up to 88% of patients with VLU may receive compression therapy [4].

A 2010 study by the U.S. Wound Registry showed that patients with venous ulcers were provided adequate compression in fewer than 17% of visits, even at hospital based outpatient wound centers. [5]

Some of the reasons why compression therapy is underutilized are: lack of knowledge or confidence by clinicians, unclear referral pathways because of the variety of specialties that may be involved, local unavailability of compression bandages or hosiery and unwillingness of patients to wear compression therapy [3].

How the intervention works

Most VLU are associated with chronic venous insufficiency, however the etiology of VLU is not yet fully understood [1][6]. Chronic venous insufficiency has been shown to be associated with venous hypertension [7], which most often results from thrombosis and/or valve disease affecting the superficial, perforator or deep veins [2]. In individuals with healthy venous valves, calf muscle contraction during ambulation (muscle pump) reduces the intravenous pressure at the ankle during, however in venous dysfunction pressure remains high resulting in ambulatory venous hypertension (Video 1, Figure 1) [8][9]. Venous hypertension results in inflammatory alterations with microcirculatory changes that can culminate in edema, venous stasis and VLU [10].

Video 1. Muscle pump

Figure 1 – Changes in pressure (measured at the ankle) in venous system of individuals with healthy and dysfunctional venous valves during lying, rising, standing and exercise

External compression has been used in an attempt to reverse venous hypertension and aid venous return [7]. Venous stasis and edema can be reduced by effectively applying external local compression which facilitates reabsorption of fluid from the interstitium into the lymphatics (Figure 2) [8]. This phenomenon has been described by the Starling equation (Figure 3) [8][11].

Figure 2. The mechanism of action on compression

Figure 3. Starling equation

Working pressure and resting pressure: to understand how compression therapy works, it is necessary to understand the difference between working and resting pressure [12].

Resting pressureis the result of compression of the extremity at rest. It corresponds to the force exerted by the bandage when the muscles are relaxed.

Working pressureis the pressure generated through the interaction of muscle contraction and the compression bandage when walking; it results from the resistance the bandage exerts to counteract muscle movement. The less the bandage yields in this process, the higher the working pressure and the stiffer/inelastic the bandage is.

Both kinds of pressure depend on several factors. Given that the working pressure is generated by active muscle contraction, it is always higher than the resting pressure.

Factors that affect pressure delivered:

Compression device-related:

Material used: inelastic components have high stiffness and so usually produce lower resting pressures but higher working pressures.

Number of components applied: stiffness increases with the number of components applied. Although the single components of multi-component bandages (e.g, 4 layer bandages) are elastic, the final product has properties of an inelastic bandage [13].

Clinician-related: pressure applied and application skills. Many clinicians are not familiar with compression therapy in general [14]. Compression application skills and available resources can affect sub-bandage pressure (i.e., pressure measured underneath the [2]. Even clinicians who are confident in their ability to apply compression can apply compression in a suboptimal way [15][16]. Some bandages offer visual guides that indicate proper application of the device. add how to apply

Other important facts about compression, explained by 2 physical laws: Pascal's law (Figure 4) and Laplace's Law (Figure 5) [8]

The same tension applied at the ankle will generate more pressure than if applied at the calf, due to the smaller radius at the ankle [17].

More layers of elastic compression bandaging incrementally increase compression and result in a less elastic bandage. This is in part due to friction between the layers [18].

The calculated value for sub-bandage pressure is the average pressure that will be exerted by a bandage on a limb of known circumference. Padding can be applied beneath compression bandages to reduce local variations in sub-bandage pressure [17].

Bandage width matters. A 10cm wide bandage applied with a total force of 'F' Newtons will produce only half the pressure a 5cm wide bandage applied with the same force, as the force is distributed over twice the area [17].

Figure 5. Laplace’s Law. Pressure applied by compression is proportional to the tension at the interface with skin and inversely proportional with limb radius

Compression levels

Sub-bandage pressure is measured in mmHg at the ankle level. Classification of pressure exerted by compression devices varies across countries. Pressure measured in vivo in the medial gaiter area in the supine position for training purposes may be classified into the following categories (Table 1) [19]:

Table 1. Pressure measured in vivo in the medial gaiter area in supine position for training purposes, as per the International Compression Club [19]

Classification

Pressure (mmHg)

Mild

<20

Moderate

≥20-40

Strong

≥40-60

Very strong

>60

General Indications and Contraindications

Indications

Different pressure levels are indicated according to the severity of the diseased being treated [8]. The CEAP (Clinical - Etiology -Anatomy - Pathophysiology) classification system has been used to standardize documentation and description of the manifestations of chronic venous disease. The C (Clinical) category is divided as shown inTable 2. Table 3 summarizes indications and pressure levels commonly used in compression therapy for chronic venous disease.

Contraindications

Severe peripheral arterial disease (PAD): all patients should be screened for arterial disease using Doppler measurement of the ankle-brachial pressure index (ABI) or Doppler continuous waveform analysis [25] by trained staff before receiving compression therapy [1]. Inadequate compression on a limb compromised by arterial disease can lead to ischemic sequelae and tissue necrosis [26]. ABI below 0.8 is often considered clinically significant PAD.

Patients with ABI between 0.5 and 0.8 may be eligible to receive modified (reduced) compression (20-30 mmHg at the ankle), pending vascular assessment and/or indication by a vascular specialist [1][27].

Acute DVT: if present, acute DVT needs to first be treated with anticoagulants for 7 days before compression therapy is started [29].

Untreated cellulitis: if present cellulitis needs to first be treated with systemic antibiotics for 24 hours and the patient should be afebrile before compression therapy is applied [3]. Patients can receive reduced compression if standard compression is difficult to tolerate. Dressing change frequency can be increased to monitor infection.

Types of compression therapy devices

Adequate compression can be achieved by several methods, including use of a single component or layer (such as a compression stocking or one type of bandage) or using multiple components or layers (different types of bandages or stockings and bandages used together) [1][30]. Overall, evidence shows that multi-component systems are more effective than single-component systems. High compression is more effective than low compression, but among different types of high compression no clear differences have been observed [1].

All patients who are candidates for compression therapy should have their ABI, doppler waveform or toe brachial index (TBI) measured and recorded [3]. Assessment of arterial blood supply with these tests is a major determinant of the pressure level of compression to be applied. Other factors that influence choice of compression devices are: clinician’s preference and experience, wound status, exudate level, patient mobility, ability of the patient to self-apply compression, patient’s preferences, pain level, access to care, level of compression required, and availability of compression systems [3]. For decision support on choices for effective compression therapy, see "How to Select Adequate Compression Therapy Pressure Levels and Products". For information on major brands of compression devices, see "Compression Brands Quick Reference".

In general, compression devices for treatment of VLU can be classified as static or dynamic:

Static:Compression bandagesandgradient compression stockingsare forms of static compression and apply a constant pressure gradient from distal to proximal in the extremity [3][31]. This gradient of a 20–30% reduction in pressure from ankle to below knee is thought to aid venous return to the heart and occurs naturally when compression is applied to a limb of normal proportions due to the principles of Laplace’s Law [31]. Patients with altered limb shape, such as inverted champagne bottle shape, may require reshaping of the limb with padding prior to the application of compression in order to benefit from graduated compression. However, it is not clear how important this gradient is, especially for mobile patients [31].

Dynamic:Intermittent pneumatic compression (IPC)is an example of dynamic compression. The sequential inflation and deflation of the chambers creates intermittent pressure peaks, mimicking the effect of the calf muscle pump and offering a number of benefits. It may be useful for patients with reduced mobility or wasting of the calf muscle [31].

Static or dynamic compression devices can be elastic, inelastic or a combination of both:

Elastic: elastic systems (also known as “long stretch”) contain elastomeric fibers and are capable of stretching and returning almost to their original size. They can sustain pressure for up to a week due to their ability to accommodate changes in limb shape and movement [9][31]. Elastic compression provides compression when patients are either walking or resting, which may not be desirable in patients with PAD [2].

Inelastic: inelastic systems contain no or few elastomeric fibers. They include “non-stretch” materials, such as zinc paste bandages, and “short-stretch” materials, which have a minimal extensibility (SSB) [31]. Inelastic systems can maintain levels of 30-60 mmHg in the first 24 hours after application, but this level decreases with movement of fluid and edema reduction. Most multi-component systems (two and four-components) function as an inelastic system even if they contain mainly elastic components [9]. Inelastic systems will produce higher pressures during standing and lower pressures when lying down than elastic systems [2][9] making it more desirable in patients with mild arterial insufficiency[2].

Combination: compression system composed of both elastic and inelastic materials. Multi-component layers (e.g. Profore) behave as an inelastic or high stiffness system [13].

High or low stiffness:

Single or double-layer bandages are characterized by use of the terms ‘‘elastic and inelastic". Final behavior of kits or systems (e.g., multi-component systems) is characterized as ‘‘high or low stiffness’’ [19]. Stiffness may be characterized by the increase of interface pressure measured in the gaiter area when standing up from the supine position [19].

High stiffness: Inelastic behavior. A pressure increase of > 10 mmHg measured in the gaiter area when standing up from supine position is characteristic of a stiff bandage system [19].

Low stiffness: Elastic/long stretch behavior. A pressure increase of < 10 mmHg measured in the gaiter area when standing up from supine position.

Inelastic bandages are useful when frequent dressing changes are needed due to weeping or when there is pressure damage from elastic bandages [29][31], and for patients with mild/moderate PAD [2]. Not indicated for patients with reduced mobility as it requires functional muscle pump to be effective [32].

Inelastic bandages may be more adequate for patients with mild PAD [2]. Inelastic systems can maintain 30-60 mmHg in the first 24 hrs, but decreases with movement and edema reduction [9][31].

Clinical guidelines suggest multi-component compression systems with an elastic component (4LB) as the first choice of initial therapy for most patients with VLU with no contraindications [1][33]. Even with elastic component, a 4LB behaves as a high stiffness, inelastic system.

4LB has been shown to be more cost-effective than multi-component compression systems without an elastic component in the U.K. [34][35]. In practice, patient adherence to 4LB may be lower than to 2LB. Most multi-component compression systems are designed to deliver 40 mmHg at the ankle, decreasing to around 17 mmHg at the calf.

Can be used as a first-line treatment for patients with small, uncomplicated ulcers who wish to self-care and who find bandages too hot or bulky [31] and patients without morbid obesity, lipodermatoesclerosis or severe edema [37]

Custom fitt stockings may provide adequate compression to patients, however they are difficult to don and may lead to low adherence to therapy [38]

Two-layer compression stockings (HH) that deliver 40 mmHg are as effective in healing VLU as 4LB and they appear to have additional benefit of reducing recurrence rates and being more cost-effective [37]

Patients who are unable to wear 35 to 45 mmHg gradient compression stockings because of weakness or arthritis or those who are unable to tolerate inelastic non-stretch compression bandage (e.g. Unna boot) [39]

Inelastic compression provided by Velcro bands, can be adjusted as limb swelling decreases. Provides higher working and lower resting compression levels with low-stretch materials. A lower resting compression level can make it more tolerable to patients

Patients with VLU who cannot wear or tolerate any of the other compression methods due to severe PAD, excessive pain, pressure damage [29], severe difficulty in donning compression stockings or have failed to respond to prolonged compression therapy alone [26]

Patients with VLU with reduced mobility or wasting of the calf muscle [31]

Whereas it is advantageous to use IPC compared with no compression therapy, currently there is limited evidence to suggest that the addition of IPC to compression therapy offers benefit [26][40]

Pressure levels are generally set to 50 mmHg but are never greater than diastolic pressure [32]

Two-layer gradient compression stockings (HH) that deliver 40 mmHg pressure at the ankle can be considered an effective alternative to multi-component compression systems (4LB) (Grade 2B).

2C

Intermittent pneumatic compression (IPC) therapy can be used when all other compression therapy methods have failed or on patients that do not tolerate multi-component compression systems or high compression gradient stockings (Grade 2C).

2C

To decrease risk of ulcer recurrence in patients with a healed VLU, we suggest compression therapy with gradient compression stockings at the highest pressure patients can tolerate (Grade 2C).

Practice Tips

Choosing an ideal compression device

With the goal of achieving optimal sub-bandage pressure and gradient compression, clinicians should choose the type of compression device according to availability of resources, clinicians’ experience and familiarity with the compression method, characteristics of the ulcer, patient preference and support from caregivers. For decision support on choices for effective compression therapy see "How to Select Compression Therapy". For information on major brands of compression devices see "Compression Brands Quick Reference".

Compression for VLU patients with CHF and PAD

For patients with CHF or history of CHF: if patient is stable, modified compression should be applied as long as patient is being treated and under control. If needed, diuretics can be increased upon application of compression for the first time and patient should be reassessed within 24-48 hours.

For patients with PAD and ABI between 0.5 and 0.8, use reduced level of compression (20-30 mmHg at the ankle) and closely monitor for complications. If resources are available and if uncertain about whether compression can be applied, clinicians can measure toe pressure with the patient lying in dorsal decubitus before and immediately after application of modified compression (e.g., SSB like Coban™ 2 Lite). Clinicians have reported increased toe pressure after SSB application.

Get a head start on reducing edema

If a patient with VLU has significant edema and no CHF, and resources and time are available, a quick course of high pressure compression (e.g., with Ace wrap) can be applied to the patient’s leg for 10-20 minutes in the clinic before applying the dressings and compression bandages/stockings/wrap that the patient will go home with. Practitioners have seen patients lose 1-2 cm in leg diameter with the addition of this step.

Risks and Complications

Most complications due to compression therapy are avoidable if appropriate measures to mitigate risks are taken. If complications arise, it is important that they be addressed promptly. Below are some of the complications and a few practical suggestions to manage them [31]:

Pain: compression, when applied appropriately should reduce pain. However, effective compression may cause initial discomfort and anxiety. Suggestions based on expert opinion include:

Rule out any other causes of pain, such as PAD-related pain. Teach patient to recognize signs of PAD (e.g., changes in limb color/perfusion)

Ensure overlap is even mainly at the dorsum of the foot, ankle and calf

Loss of calf muscle: may be seen in patients receiving long-term compression, most likely due to reduced patient activity and underlying comorbidities (as opposed to compression itself). Suggestions based on expert opinion include:

Ensure compression allows patient to flex knee and ankle at or near 90 degrees

Skin problems: can arise due to excessive exudate or allergic reactions. Suggestions based on expert opinion include:

Fungal infection: excessive exudate can lead to fungal infection. Fungal infection needs to be treated to resolution before reapplication of occlusive dressings and compression. Prevent fungal infections by adequately managing exudate (see local wound care) and increasing frequency of dressing and compression system change until exudate is controlled.

Contact dermatitis: susceptible patients may develop contact dermatitis from one of the components of the compression system (e.g., latex, zinc, wool). Remove irritant or use a cotton stockinette liner or paste bandage against the skin to avoid irritation from wool padding.

Patient Adherence

Many patients cannot tolerate, or do not adhere to, compression bandaging therapy [41]. It is estimated that 60-70% of patients do not appropriately adhere to compression therapy [42][43]. Patients might find it difficult to tolerate compression due to several reasons, such as bandage bulk, lifestyle, climate or cultural factors [31]. Patients with obesity, frailty or arthritis will struggle to apply elastic compression stockings. Also, patients’ beliefs that compression is unnecessary and uncomfortable, or conversely that is worthwhile and prevents recurrence, affects adherence or non-adherence [44]. Thus, adherence can be improved by educating patients on the importance of compression therapy [45], and also by properly selecting the best compression alternative for each patient.

Below are some practical suggestions based on expert opinion to aid in patient adherence [3]:

Determine reasons for non-concordance and address any modifiable reason

Consider implementing lower level of compression and gradually increasing to a level that is tolerable for the patient

Consider the use of compression hosiery, tubular compression or IPC associated with hosiery

Limit bulk around the ankle/foot

Bandage protector to enable bathing/showering

Transitioning to Stockings

For simple VLU, when adherence is not an issue and patient is able to don gradient compression stockings: as ulcer is decreasing in size and complete healing is likely in about 2 weeks, gradient compression stockings can be prescribed and ordered (covered by Medicare if ulcer is active, not healed). After ulcer is healed, compression bandages may continue to be applied for 1-2 weeks to avoid damaging fragile newly healed area.

For complex VLU, mixed etiology leg ulcers or when adherence is an issue: consult edema management specialist (e.g., physical therapist) early on (e.g., after initial evaluation), as patient education and choice of long-term compression according to patient preference and life-style may take several weeks.

PATIENT EDUCATION FOR CLINICIANS

VLU are a chronic, long-term problem with recurrence rates as high as 70%. Therefore, long-term maintenance must be addressed even for healed ulcers [47]. See “Venous Ulcers” section on ‘Patient Education’ for details on patient education for VLU healing, prevention of new VLU and prevention of recurrence.

Overall, compression bandages, wraps and certain gradient compression stockings are covered by Medicare Part B under the Surgical Dressing Benefit as long as used on patients with active VLU. IPC also may be covered at least partially, if applied or supervised by a home visiting nurse or if utilized in a hospital or nursing home setting.

If a provider applies compression bandages or wraps as part of a professional service that is billed to Medicare, these supplies are considered incident to the professional services of the healthcare practitioner and are not separately payable. Claims for the professional service, which includes the supplies, must be submitted to the local carrier or intermediary. If compression bandages or wraps are sent home with the beneficiary, claims for these dressings may be submitted as durable medical equipment (DME). In this situation, use the place of service corresponding to the beneficiary's residence; Place of Service Office (POS=11) must not be used.

venous insufficiency without VLU, prevention of new VLU, prevention of recurrence of VLU that have healed, treatment of lymphedema in the absence of VLU

Gradient compression stockings 30-40, 40-50 mmHg

A6531, A6532

1 per 6 months/leg

be used to treat VLU

Gradient compression stockings other than above

A6530, A6533-A6544

A6549

n/a

not covered for any indication

Other

Surgical stockings

A4490-A4510

n/a

not covered for any indication

Non-elastic binder

A4465

n/a

* unless part of a multicomponent system

** When multi-layer compression bandage systems are used for the treatment of a VLU, each component is billed using a specific HCPCS II code for the DME component.

CMS QUALITY MEASURES

Below are measures that are directly related to compression therapy for VLU. For other measures related to VLU see “Venous Ulcers” section ‘CMS Quality Measures’. For a comprehensive list of wound care related measures see “Wound Care Quality Measures”.

MIPS currently does not have VLU-specific measures. Listed below are VLU/compression therapy-specific measures issued by the qualified clinical data registry (QCDR) US Wound Registry.

QCDR

Title

Description

ID

Measure Type

US Wound Registry (USWR)

Adequate Compression at Each Visit for Patients with VLUs

Percentage of venous leg ulcer visits of patients aged 18 years and older that received adequate compression within the 12-month reporting period.

NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.